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Trial record 7 of 7 for:    "Milroy disease"

Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced PCD

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ClinicalTrials.gov Identifier: NCT02661646
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Tactile Medical

Brief Summary:
Assessment of QOL and symptoms changes in primary or secondary, unilateral or bilateral lower extremity patients using an advanced pneumatic compression system.

Condition or disease Intervention/treatment
Lymphedema Device: Advanced Pneumatic Compression Device

Detailed Description:
Multi-centered, single arm, observational clinical trial of a prospective cohort of an estimated 300 participants with primary or secondary, unilateral or bilateral, lower extremity lymphedema. All participants receive intermittent pneumatic compression treatment for 52 weeks. Quality of life and symptoms will be assessed pre- and post - intermittent pneumatic compression treatment at 12, 24 and 52 weeks.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device at Home
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
Advanced Pneumatic Compression Group
All study participants will receive treatment using an advanced pneumatic compression device.
Device: Advanced Pneumatic Compression Device
Advanced Pneumatic Compression Device
Other Name: Flexitouch system




Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 weeks ]
    Questionnaires to assess quality of life changes after 12 weeks of treatment

  2. Symptom changes [ Time Frame: 12 weeks ]
    Symptom changes after 12 weeks of treatment


Secondary Outcome Measures :
  1. Limb circumference changes after 12 weeks of treatment [ Time Frame: 12 weeks ]
  2. Limb circumference changes after 52 weeks of treatment [ Time Frame: 52 weeks ]
  3. Compliance [ Time Frame: Study duration ]
  4. Skin changes after 12 weeks of treatment [ Time Frame: 12 weeks ]
  5. Skin changes after 52 weeks of treatment [ Time Frame: 52 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary or secondary, unilateral or bilateral lower extremity lymphedema patients using the Flexitouch system during a 12 week study period.

*Note: Only Veteran's are eligible as this study is run through The Department of Veterans Affairs New York Harbor Healthcare System.

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of primary or secondary, unilateral or bilateral lower extremity lymphedema
  • Ability and willingness to participate in all aspects of the study and ability to provide informed consent.
  • Must have a prescription for the study device

Exclusion Criteria:

  • Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer.
  • Diagnosis of acute infection. The source of the infection must be treated for 2 weeks prior to admittance into the study.
  • Acute thrombophlebitis (in last 2 months)
  • Pulmonary embolism or deep vein thrombosis within the previous 6 months
  • Pulmonary edema
  • Class IV congestive heart failure
  • Patients with poorly controlled asthma
  • Previous use of the study pneumatic compression device
  • Currently using multi-layer bandaging
  • Pregnant women or women of childbearing potential not on contraception
  • Any condition where increased venous and lymphatic return is undesirable
  • Currently participating in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661646


Contacts
Contact: Jill Christensen jchristensen@tactilemedical.com
Contact: Elyse Monte emonte@tactilemedical.com

Locations
United States, New York
VA NY Harbor Healthcare System - Brooklyn Recruiting
Brooklyn, New York, United States, 11209
Principal Investigator: Thomas Maldonado, MD         
VA NY Harbor Healthcare System - St. Albans Recruiting
Jamaica, New York, United States, 11425
Principal Investigator: Thomas Maldonado, MD         
VA NY Harbor Healthcare System - Manhattan Recruiting
New York, New York, United States, 10010
Principal Investigator: Thomas Maldonado, MD         
Sponsors and Collaborators
Tactile Medical
Investigators
Principal Investigator: Thomas Maldonado, MD NYU

Responsible Party: Tactile Medical
ClinicalTrials.gov Identifier: NCT02661646     History of Changes
Other Study ID Numbers: 5010
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tactile Medical:
Chronic Swelling
Leg Lymphedema
Primary Lymphedema
Secondary Lymphedema

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases